Monday, February 4, 2019

GB/T32230: Quality Culture and the Medical Laboratory.

So I was browsing in this month’s Quality Progress (January 2019) and found an interesting article written by Ningning Jing about Quality Culture, a topic about which I have a lot of interest.  What caught my eye was that in 2015 a new guideline was created and subsequently published by China Standard Press entitled Chinese National Standard, GB/T32230-2015—Guidelines for Quality Culture Development in Enterprises.  I was unable to find an ISO equivalent, so I am unsure where or how the Standardization Administration of China (SAC) developed guideline.  As it turns out it is available in English, but it was fairly expensive

The guideline makes for some interesting reading.  It reminded me of how much medical laboratories have changed over the last 15 years, dating in my mind back to the original publication of ISO15189:2003 (Medical laboratories – the particular requirements for quality and competence).   

Laboratory life has changed a lot since those early days.  Despite the awareness of some of the efforts of W Edwards Deming and perhaps of Armand Feigenbaum and Total Quality Management in the 1980s, for the most part, quality in the medical laboratory was largely mechanical and technical.  The concepts of quality were mostly about accuracy and documentation, and very little about timeliness, or appropriateness, or clinical relevancy.  The quality dynamic was the laboratory, the physician customer and the specimen.

Quality principles as expressed in ISO15189:2003 made a material change because it introduced concepts of Quality Managers and patients and the needs and requirements of the staff.   In today’s medical laboratory, quality has expanded to address satisfaction, and interested parties and stakeholders and service excellence.  Modern laboratory quality is an essential component of every aspect of the total experience.

Today many almost every laboratory conference and education program and continuous improvement program for medical laboratorians will focus on some aspect of the essentialness of a Culture for Quality.

What many may not realize is that Quality Culture is not a new concept.  Joe Batten has been writing on the topic going back to 1992.   Back then Batten presented a definition of Culture that I still rely upon today [Culture: The pervasive philosophy, central values, beliefs, attitudes and practices of an organization, and the micro-elements that make things happen.] 

While I still have my old copy of Building a Total Quality Culture, I see it is no longer available even on Amazon, but I see there is a new edition (2014) available.
This new guideline defines quality culture as the “total of quality concepts and values, habits and behavior patterns, basic principles and systems as well as their material performance recognized by the enterprise and its staffs”.  With interest, ISO 9000:2015 provides a similar definition: “a culture that results in the behaviour, attitudes, activities and processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties”  When either of these variation definitions is combined with the one used by Batten, back in 1992 you capture a clear picture of Quality Culture. 

The new guideline makes several points: (a)  the culture must be driven and directed from the top; (b) that without leadership, a quality culture is unlikely to happen.  And (c) that leadership by itself is insufficient and if the staff are not engaged then the process with fail.  (I am reminded of Feigenbaum who said that Management is responsible for 80 percent of Quality, with the organization sharing the responsibility of the 20 percent).  (d) the document reminds that Quality Culture is NOT a cookie-cutter operation.  Each organization is unique and their culture must have the freedom to reflect that.  And importantly (e ) building a Quality Culture is NOT a one-and-done activity; culture is a philosophy/attitude that must mature and change with experience.   

Importantly the new guideline urges that to ensure that the organization has implemented a truly effective program, it has to find a way to measure its impact, which begs the question, can one really measure an attitude?  Well the important answer is “yes, you can!” 

In our course on Laboratory Quality Management we talk about Quality Culture, and provide some ideas on how culture measurement can be done and more  to the point, illustrate how it is possible to assist culture realignment when the organization’s changing needs require. 

I have not yet taken the opportunity to read the guideline thoroughly, but so far I am pretty impressed.  I suspect that when the crafters of GB/T32230-2015 were thinking about “enterprises”,  medical laboratories were no where on their list.  But they have done us a valuable service. 
Do I think that the new version of ISO 15189: 202(?) will incorporate some elements of quality culture?  I would be pleasantly surprised if it did. 

But regardless, it is well worth the read.